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HLA-B*5801 Screening to Prevent Allopurinol-induced Severe Cutaneous Adverse Reaction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03046914
Recruitment Status : Unknown
Verified February 2017 by Heung-Woo Park, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : February 8, 2017
Last Update Posted : February 8, 2017
Ministry of Food and Drug Safety, Korea
Information provided by (Responsible Party):
Heung-Woo Park, Seoul National University Hospital

Brief Summary:
Allopurinol-induced severe cutaneous adverse reaction (SCAR) is a rare but fatal condition. Previous reports have reported that HLA-B*5801 is an important genetic risk factor significantly associated with the development of allopurinol-induced SCAR. However, there has been no prospective study to prove the clinical efficacy of a HLA-B*5801 screening before administration of allopurinol in predicting allopurinol-induced SCAR. The purpose of this prospective study is to test our hypothesis that a pre-screening of HLA-B*5801 will significantly reduce the risk of allopurinol-induced SCAR development compared to the historical control.

Condition or disease Intervention/treatment Phase
Stevens-Johnson Syndrome Kidney Failure, Chronic Genetic: HLA-B*5801 test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective cases and historical controls
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Prospective Study to Prove the Usefulness of HLA-B*5801 Screening Test for the Prevention of Allopurinol-induced Severe Cutaneous Adverse Reaction in Patient With Chronic Kidney Disease
Actual Study Start Date : February 24, 2016
Estimated Primary Completion Date : November 30, 2017
Estimated Study Completion Date : November 30, 2017

Arm Intervention/treatment
Experimental: HLA-B*5801 screen test
An arm in which a participant takes HLA-B*5801 test before administration of allopurinol
Genetic: HLA-B*5801 test
Check whether a participant has HLA-B*5801 allele or not, before administration of allopurinol

Primary Outcome Measures :
  1. An occurrence of allopurinol-induced severe cutaneous adverse reaction [ Time Frame: Before 3 months after initiation of allopurinol ]

    # Clinical presentations

    • Stevens-Johnson syndrome (SJS), SJS/Toxic epidermal necrolysis (TEN) overlap and TEN were diagnosed according to the range of detached surface area (< 10 %, 10-30 %, and > 30 %, respectively).
    • Drug rash with eosinophilia and systemic symptoms (DRESS) was diagnosed with the following criteria; Hospitalization, Reaction suspected to be drug-related Acute rash, Fever >38°C*, Enlarged lymph nodes at a minimum of 2 sites*, Involvement of at least 1 internal organ*, Blood count abnormalities*, Lymphocytes above or below normal limits, Eosinophils above the laboratory limits, Platelets below the laboratory limits [Three out of four asterisked (*) criteria are required for making the diagnosis.]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • a subject who needs an allopurinol treatment based on the physician's assessement
  • a subject with chronic kidney disease (CKD)

    • CKD is diagnosed on at least 2 occasions for a period of at least 3 months, irrespective of the underlying cause and on the basis

      1. an estimated or measured glomerular filtration rate <60 mL/min/1.73 m2 and/or
      2. evidence of kidney damage (albuminuria, proteinuria, haematuria after exclusion of urological causes, or structural abnormalities on kidney imaging tests)

Exclusion Criteria:

  • a subject who refuses to participate in this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03046914

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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Heung-Woo Park, PhD    +82-2-2072-0699   
Contact: Jung-In Park    +82-2-2072-4849   
Sponsors and Collaborators
Seoul National University Hospital
Ministry of Food and Drug Safety, Korea

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Responsible Party: Heung-Woo Park, Professor, Seoul National University Hospital Identifier: NCT03046914     History of Changes
Other Study ID Numbers: SNUIMA002
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: February 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stevens-Johnson Syndrome
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Mouth Diseases
Stomatognathic Diseases
Drug Eruptions
Skin Diseases
Erythema Multiforme
Skin Diseases, Vesiculobullous
Drug Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Protective Agents
Physiological Effects of Drugs